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PRIMA/ENGOT-OV26/GOG-3012 study: Updated long-term PFS and safety

Autores: González Martín, Antonio; Pothuri, B.; Vergote, I. B.; Graybill, W.; Mirza, M. R.; Mccormick, C.; Lorusso, D.; Freyer, G.; Backes, F.; Baumann, K. H.; Redondo-Sánchez, A.; Moore, R. G.; Vulsteke, C.; O'Cearbhaill, R. E.; Malinowska, I.; Shtessel, L.; Compton, N.; Monk, B. J.
Título de la revista: ANNALS OF ONCOLOGY
ISSN: 0923-7534
Volumen: 33
Número: SUPPL 7
Páginas: S789
Fecha de publicación: 2022
Background Niraparib (nir) has shown PFS benefit as a first-line (1L) maintenance therapy (MT) in the PRIMA primary analysis (data cut 17 May 2019) in all subgroups regardless of biomarker status. These results were the basis for approval of nir as MT after response to 1L platinum-based chemo (CT). Here we report updated long-term efficacy and safety in the PRIMA study. Methods This double-blind, placebo (PBO)-controlled phase 3 trial evaluated nir in pts with newly diagnosed advanced high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (OC) with a complete or partial response (CR or PR) to 1L platinum-based CT. Stratification factors were best response to 1L CT regimen (CR/PR), receipt of neoadjuvant CT (NACT; yes/no), and homologous recombination deficiency (HRD) status (HRd/HRp/HRnd) per Myriad myChoice HRD test. Pts received nir or PBO QD (2:1 ratio). The primary endpoint of PFS by blinded independent central review was concordant with investigator assessment (INV). Updated (ad hoc) data are by INV, as of 17 Nov 2021. Results Of 733 randomized pts (nir, 487; PBO, 246), 373 (51%) were HRd (nir, 247; PBO, 126), and 249 (34%) were HRp (nir, 169; PBO, 80). Overall, 35% had stage IV disease, 67% received NACT, and 33% had a PR to 1L CT. As of 17 Nov 2021, median PFS follow-up time was 3.5 y. Nir-treated pts (HRd/HRp/overall) received continued PFS benefit vs PBO (Table). All subgroups showed a sustained and durable treatment effect. The most common grade ¿3 adverse events in the nir arm were thrombocytopenia (40%), anemia (32%), and neutropenia (21%). No related on-treatment deaths occurred. MDS/AML were reported at the same incidence in nir 6/484 (1.2%) and PBO 3/244 (1.2%) arms. OS remains immature at 41% for the overall population; 33% of PBO vs 9% of nir pts received subsequent PARPi (Table: 530P). Conclusions Nir maintained clinically significant improvement in PFS with 3.5 y of follow-up in pts with newly diagnosed advanced OC at high risk of progression irrespective of HRD status. No new safety signals were identified. Clinical trial identification NCT02655016